Qa specialist Jobs in San diego ca

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Job Title :

Quality Assurance Specialist Sterile - Fill and Finish

Summary of Objective :

This full-time position will report to the Quality Manager - Sterile Fill Finish focusing on supporting the Quality department with review and release of executed batch records, product inspection, product or raw material release, document control, production monitoring, environmental monitoring, tracking quality metrics and assisting with validations, preventative actions, audits and continuous improvement. This position is responsible for performing quality activities within the Sterile Fill and Finish group in accordance with all applicable procedures, regulations, and safety directives. This individual’s primary job function will be review and release finished lots of drug product vials and syringes manufactured by PCI. Other job functions may be required at the discretion of management and include but are not limited to drafting procedures, sampling raw materials or finished products, assisting in general operations of the zero human intervention isolators all in accordance with GMPs and established SOPs

Essential Duties and Responsibilities :

• Perform product lot disposition by reviewing executed manufacturing batch records for completeness, accuracy, and compliance to GMP and company procedures.
• Perform document change control activities as needed.
• Perform and lead in investigations, NCMRs and complaints.
• Track and monitor CAPAs.
• Train new employees as needed.
• Support distribution and labeling activities.
• Collect quality metrics.
• Support the Sterile Fill and Finish Quality Manager with internal, supplier, regulatory and customer audits.
• Perform line clearances, in-process checks and monitoring of sterile manufacturing and finished product visual inspection.
• Perform finished product visual inspection or incoming release of incoming GMP materials according to appropriate material specifications.
• Ensure department and company goals are met.
• Reviews completed documentation and provided recommendations for process improvements to support existing procedures for continual improvement in conjunction with management.
• Capable of supporting sampling, packaging, and labeling operations.
• Performs GMP tasks by executing steps as written through established procedures with minimal supervision.
• Effectively communicates both verbally and in writing with all levels.
• Performs setup and operation of equipment such as Isolators, visual inspection light booth, and Biological Safety Cabinets.
• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

Required Qualifications :

Preferred :

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